Intraoperative HypotensionHYPENCT03376347
Intraoperative Implementation of the Hypotension Probability Indicator
A study testing FlotracIQ with HPI algorithm in people with Intraoperative Hypotension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Reducing intraoperative hypotension using FlotracIQ with HPI software. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- FlotracIQ with HPI algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Nov 2017to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours
- Planned to receive general anaesthesia
- Planned to receive an arterial line during surgery
- Aim for MAP of 65 mmHg during surgery
- Being able to give written informed consent prior to surgery
Who cannot join
- Aim for MAP other than 65 mmHg at discretion treating physician
- Significant hypotension before surgery defined as a MAP <65
- Right- or left sided cardiac failure (e.g. LVEF<35%)
- Known cardiac shunts (significant)
- Known aortic stenosis (severe)
- Severe cardiac arrhythmias including atrial fibrillation
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- Requiring dialysis
- Liver surgery
- Vascular surgery with clamping of the aorta
- Perioperative Goal Directed Therapy (PGDT) protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial
Reducing intraoperative hypotension using FlotracIQ with HPI software.
Read the detailed description
Intraoperative hypotension occurs often. Even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia. Currently treatment of these hypotensive episodes is not proactive. Edwards Lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. Hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.
- Conditions
- Intraoperative Hypotension
- Being tested
- FlotracIQ with HPI algorithm
- Keywords
- intraoperative, hypotension, Hypotension Probability Index, HPI
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlotracIQ with HPI algorithmDevice
FlotracIQ with hypotension probability indicator (HPI) algorithm connected to arterial line. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and what. Timing of treatment and choice of treatment is then left to the discretion of the attending physician.
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | No intervention | Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered. |
| Treatment arm | Active comparator | FlotracIQ with HPI algorithm. Receives: Device: FlotracIQ with HPI algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
TWA hypotension (measured with FlotracIQ)
Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min
Measured: intraoperative, starting 15 minutes after induction
Secondary outcomes (9)
Incidence of hypotension (measured with FlotracIQ)
Incidence of hypotension, defined as MAP <65mmHg for ≥1min
Measured: intraoperative, starting 15 minutes after induction
Time spent in hypotension (measured with FlotracIQ)
Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min
Measured: intraoperative, starting 15 minutes after induction
TWA hypertension (measured with FlotracIQ)
Time weighted average spent in hypertension, defined as MAP >100 mmHg for ≥1min
Measured: intraoperative, starting 15 minutes after induction
Percentage of time in hypertension (measured with FlotracIQ)
Percentage of time in hypertension, defined as MAP >100 mmHg for ≥1min
Measured: intraoperative, starting 15 minutes after induction
Incidence of hypertension (measured with FlotracIQ)
Incidence of hypertension, defined as MAP >100 mmHg for ≥1min.
Measured: intraoperative, starting 15 minutes after induction
Treatment choice (CRF, EPD)
Medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Measured: intraoperative, starting 15 minutes after induction
Treatment dose (CRF, EPD)
Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Measured: intraoperative, starting 15 minutes after induction
Time to treatment (CRF)
time to treatment of hypotension, defined as MAP <65mmHg for ≥1min. A study member is present at the OR to make notes
Measured: intraoperative, starting 15 minutes after induction
Diagnostic guidance protocol deviations (CRF)
Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.
Measured: intraoperative, starting 15 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start8 Nov 2017
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- M.W. Hollmann, MD, PhD, Principal investigator, Academic Medical Center (AMC), Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376347
- Sponsor's protocol ID
- NL 6211501817
- Acronym
- HYPE
- Status last verified
- Jan 2020
- First submitted
- 3 Dec 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
PubMed 32065827Wijnberge M, Schenk J, Terwindt LE, Mulder MP, Hollmann MW, Vlaar AP, Veelo DP, Geerts BF. The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial. Trials. 2019 Oct 11;20(1):582. doi: 10.1186/s13063-019-3637-4.
PubMed 31601239
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03376347
- Acronym / sponsor ID
- HYPE / NL 6211501817
- Conditions
- Intraoperative Hypotension
- Keywords
- intraoperative, hypotension, Hypotension Probability Index, HPI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reducing intraoperative hypotension using FlotracIQ with HPI software.
Detailed description
Intraoperative hypotension occurs often. Even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia. Currently treatment of these hypotensive episodes is not proactive. Edwards Lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. Hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | No intervention | –Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered. |
| Treatment arm | Active comparator | Device: FlotracIQ with HPI algorithmFlotracIQ with HPI algorithm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours
- Planned to receive general anaesthesia
- Planned to receive an arterial line during surgery
- Aim for MAP of 65 mmHg during surgery
Key exclusion criteria (10 listed)
- Aim for MAP other than 65 mmHg at discretion treating physician
- Significant hypotension before surgery defined as a MAP <65
- Right- or left sided cardiac failure (e.g. LVEF<35%)
- Known cardiac shunts (significant)
- Known aortic stenosis (severe)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlotracIQ with HPI algorithmFlotracIQ with hypotension probability indicator (HPI) algorithm connected to arterial line. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and what. Timing of treatment and choice of treatment is then left to the discretion of the attending physician. | Device | Treatment arm |
Primary outcome
TWA hypotension (measured with FlotracIQ)
Time frame: intraoperative, starting 15 minutes after induction
Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min
9 secondary outcomes
Incidence of hypotension (measured with FlotracIQ)
Time frame: intraoperative, starting 15 minutes after induction
Time spent in hypotension (measured with FlotracIQ)
Time frame: intraoperative, starting 15 minutes after induction
TWA hypertension (measured with FlotracIQ)
Time frame: intraoperative, starting 15 minutes after induction
Percentage of time in hypertension (measured with FlotracIQ)
Time frame: intraoperative, starting 15 minutes after induction
Incidence of hypertension (measured with FlotracIQ)
Time frame: intraoperative, starting 15 minutes after induction
Treatment choice (CRF, EPD)
Time frame: intraoperative, starting 15 minutes after induction
Treatment dose (CRF, EPD)
Time frame: intraoperative, starting 15 minutes after induction
Time to treatment (CRF)
Time frame: intraoperative, starting 15 minutes after induction
Diagnostic guidance protocol deviations (CRF)
Time frame: intraoperative, starting 15 minutes after induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 32065827Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
- Derived from this study: PubMed 31601239Wijnberge M, Schenk J, Terwindt LE, Mulder MP, Hollmann MW, Vlaar AP, Veelo DP, Geerts BF. The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial. Trials. 2019 Oct 11;20(1):582. doi: 10.1186/s13063-019-3637-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.W. Hollmann, MD, PhD principal investigator
Academic Medical Center (AMC), Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlotracIQ with HPI algorithm in people with Intraoperative Hypotension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TWA hypotension (measured with FlotracIQ) (time frame: intraoperative, starting 15 minutes after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376347, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.